Seminars in radiation oncology
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Following combined-modality therapy for the treatment of low-grade gliomas, the assessment of treatment response and the evaluation of disease progression are uniformly challenging. In this article, we review existing response criteria, and discuss the limitations of conventional magnetic resonance imaging to distinguish between progression and treatment effect. We review the data on advanced imaging techniques including positron emission tomography and functional magnetic resonance imaging, which may enhance the interpretation of posttreatment changes, and enable the earlier assessment of the efficacy and toxicity of therapy in these patients with prolonged survival.
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Intraductal papillary mucinous neoplasm (IPMN) of the pancreas is a relatively rare cystic neoplasm. Although most IPMNs appear to be benign and may be managed by surveillance, all IPMNs are considered premalignant lesions with malignant potential. As such, current efforts are focused on identifying those neoplasms that are at high risk for malignancy to optimize treatment strategy and outcome. ⋯ The role of adjuvant therapy is unclear, and we review the evidence for chemoradiation here. Some studies suggest adjuvant chemoradiation may have the greatest impact in malignant IPMNs with adverse histologic features, that is, lymph node metastasis at the time of diagnosis or positive surgical margins. As more IPMNs are recognized and treated, more evidence will accumulate to guide clinicians regarding appropriate use of radiotherapy in the management of IPMN.
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Technological advances are a major contributor to rising costs in health care, including radiation oncology. Despite the large amount spent on new technologies, technology assessment remains inadequate, leading to potentially costly and unnecessary use of new technologies. Comparative effectiveness studies have an important role to play in evaluating the benefits and harms of new technologies compared with older technologies and have been identified as a priority area for research by the Radiation Oncology Institute. This article outlines the elements of effective technology assessment, identifies key challenges to comparative effectiveness studies of new radiation oncology technologies, and reviews several examples of comparative effectiveness studies in radiation oncology, including studies on conformal radiation, IMRT, proton therapy, and other concurrent new technologies.
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Comparative effectiveness research (CER) is especially applicable to surgical oncology because of the numerous challenges associated with conducting surgical randomized controlled trials, and the opportunity to apply various CER methodologies to answer surgical questions. In this article, several past randomized trials or attempted trials are described to demonstrate challenges related to feasibility, patient selection and generalizability, and timeliness trial results to inform clinical practice. Thus, there is a gap between these "efficacy" studies (ie, randomized trials) and "effectiveness" research, which is performed in a less controlled setting (not randomized) but is able to examine patient outcomes in the "real world." Retrospective analyses and pragmatic trials are other important methods for answering CER questions in surgical oncology, with examples of these studies being conducted in prostate, breast, and rectal cancers. Multiple current initiatives by the American College of Surgeons and the Alliance for Clinical Trials in Oncology continue to expand the infrastructure for CER in surgical oncology.
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Owing to increasing healthcare costs, there is a need to examine whether the benefits of new technologies are worth the extra cost. In proton therapy, where the evidence in favor is limited, it is heavily debated whether the expected benefit justifies the higher capital and operating costs. The aim of this article was to explore the existing methodologies of economic evaluations (EEs) of particle therapy and recommend an approach for future data collection and analysis. ⋯ We identified an urgent need to collect appropriate data to allow for reimbursement of such novel technology. In the absence of level 1 evidence, well-performed modeling studies taking into account the available cost and outcome parameters, including the current uncertainties, can help to address the problem of limited outcome and health economic data. The approach of coverage with evidence development, in which evidence is collected in an ongoing manner in population-based registries along with dedicated financing, may allow technological advances with limited initial evidence of benefit and value, such as protons, to become available to patients in an early phase of their technology life cycle.